Regulatory Focus™ > News Articles > 6 > Recon: FDA approves lower dose of Lilly-Incyte arthritis drug

Recon: FDA approves lower dose of Lilly-Incyte arthritis drug

Posted 01 June 2018 | By Ana Mulero 

Recon: FDA approves lower dose of Lilly-Incyte arthritis drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • ‘Right-to-try’ law intended to weaken the FDA, measure’s sponsor says in blunt remarks (STAT) (Endpoints) (Fierce) (Washington Examiner) (MedCity News)
  • Amgen, MD Anderson Launch Two Cancer Collaborations (GEN News) (Fierce)
  • Neoantigen pioneer Neon Therapeutics casts off in search of $115M IPO to fuel the race to a personalized cancer treatment (Endpoints) (Fierce)
  • Celgene shakeup continues: Johnson & Johnson veteran Elkins joins as CFO months before Kellogg retires (Fierce) (Endpoints)
  • FDA approves lower dose of Lilly-Incyte arthritis drug (Reuters) (STAT-$) (Endpoints)
  • J&J racks up a fresh set of positive pivotal data for depression drug esketamine — but questions linger on safety (Endpoints) (The Pharma Letter-$)
  • Oncologists sue HHS over Medicare Part B sequester cuts (Modern Healthcare) (Medscape)
  • Thanks to lower-than-expected price, ICER backs Amgen's Aimovig—but only after other drugs fail (Fierce) (PMLiVE)
  • Xynomic Pharma completes Series B fundraising, sets sights on Abex development (The Pharma Letter) (Fierce)
In Focus: International
  • Roche scraps €120M SMA drug after hitting ‘many difficulties’  (Fierce) (PharmaTimes) (Endpoints) (GEN News)
  • Tesaro's ovarian cancer drug Zejula added to Cancer Drugs Fund (PharmaTimes) (The Pharma Letter-$) (PMLiVE)
  • UN health agency backs away from call to tax sugary drinks (AP News) (Reuters)
  • Fragile Antibiotic Supply Chain Causes Shortages And Is A National Security Threat (Forbes)
  • World’s first cancer app to integrate with an EMR as Australia’s CancerAid links into Cedars-Sinai’s Epic system (Healthcare IT News)
Pharmaceuticals & Biotechnology
  • Biotech CEO Pay: Inflation Held At Bay (Forbes)
  • The FDA is sounding the alarm on the next group of drugs that could be abused (Business Insider)
  • Bayer and MD Anderson collaborate on novel targeted cancer treatments (pharmaphorum)
  • Leading oncology group wary of Trump drug price proposals (Reuters)
  • Drug costs prompt fears of ‘financial toxicity’ in cancer care (Financial Times)
  • Opinion: Putting Patients First in Drug-Pricing Decisions (Morning Consult)
  • Drug makers push back on cost-effectiveness research for Medicare drugs (STAT-$)
  • FDA wants brand and generic drug makers to get along (Axios)
  • Sanofi tweaks pricing policies, discloses 8.4% net price decline in 2017 (Fierce)
  • Amgen is the latest drugmaker to have a Herceptin biosim sidelined by a CRL (Fierce)
  • Dova reveals $9K to $13.5K Doptelet price, stock sags (BioPharma Dive) (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • The difficult search for the right recipe in cancer immunotherapy (C&EN)
  • Next-Generation Therapies in Focus at Year's Top Cancer Meeting (Bloomberg)
  • Microbiome, Herbal Medicine, and Probiotics Combine to Extend Lifespan (GEN News)
  • Ahead of ASCO, BMS' Opdivo leads Merck's Keytruda in U.S. sales—but not for long, analyst predicts (Fierce) (Press)
  • Small molecule silences cancer-driving RNA, opens up previously undruggable targets (Fierce)
  • Samsung Bioepis Announces Results of Additional One-Year Follow-up Study on SB3 Trastuzumab Biosimilar Candidate at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Press)
  • Aratana Therapeutics Files for FDA Approval of NOCITA (bupivacaine liposome injectable suspension) Label Expansion (Press)
  • Halozyme Identifies Plasma Biomarkers As Potential Predictors Of Survival In Pancreatic Cancer (Press)
  • SELLAS Life Sciences Provides Clinical Update on Phase 2b NeuVax (nelipepimut-S) Study in Combination with Trastuzumab in HER2 1+/2+ Breast Cancer Patients (Press)
  • Exelixis Announces Further Expansion to Clinical Research Protocol for Phase 1b COSMIC-021 Trial of Cabozantinib in Combination with Anti-PD-L1 Immunotherapy in Patients with Locally Advanced or Metastatic Solid Tumors (Press)
  • Immunomedics Announces Pivotal Study of Sacituzumab Govitecan in Patients With Locally Advanced or Metastatic Urothelial Cancer (Press)
  • Data Highlighting Advaxis’ ADXS-PSA Presented at ASCO Annual Meeting (Press)
  • Tonix Pharmaceuticals Presented New Data Related to Suicidal Ideation and Behaviors in Military-Related PTSD from the Phase 2 AtEase Study at the American Society of Clinical Psychopharmacology (Press)
  • Lilly to Showcase New Data at Digestive Disease Week 2018 for Mirikizumab in Moderate-to-Severe Ulcerative Colitis (Press)
Medical Devices
  • Blood test offers hope of finding cancers before symptoms develop (CNN)
  • As FDA signals wider AI approval, hospitals have a role to play (Healthcare IT News)
  • Virgo’s technology enables video recording of colonoscopies (MedCity News)
  • Telemedicine services appear to drive genetic testing (MobiHealthNews)
  • Artificial Sensory Nerves May One Day Provide Prosthetic Limbs with Sense of Touch (GEN News)
  • Korea’s IntroMedic wins FDA nod for MiroCam capsule endoscope, inks U.S. distro deal (MassDevice)
  • Startup debuts with plan to map gene signaling pathways for new targets (Fierce)
  • GE Healthcare Introduces Virtual Reality Training for Healthcare Technology Management Professionals (Press)
  • Philips provides AEDs for New Cardiac Arrest Response System (Press)
  • Branchpoint Technologies announces FDA 510(k) for its AURA Intracranial Pressure Monitoring System (Press)
US: Assorted & Government
  • FDA’s Ninth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and a New Tone (FDA Law Blog)
  • Mergers between health insurers and pharmacy benefit managers could be bad for your health (STAT)
  • Alphabet's Verily has hired top execs to bring its science research into hospitals and homes (CNBC)
  • Jamie Dimon says after health venture with Amazon and Berkshire was announced insurers were 'pissed off' (CNBC)
  • CVS donated to pro-Trump "dark money" group (Axios)
  • IBM Watson Health confirms layoffs (Axios)
  • Trump Administration Targets State Rules That Women Must Be Told of Abortion Services (WSJ)
  • Sergeant Sues Defense Dept. Over ‘Outdated’ H.I.V. Policies (NYT)
  • Why the Trump administration made it easier for Virginia Republicans to expand Medicaid (The Washington Post)
  • Four more die in E.Coli outbreak linked to romaine lettuce (Reuters)
  • UnitedHealth expects 150M members to be in value-based programs by 2025 (Fierce)
  • Planned Parenthood cancels abortion appointments in Arkansas after Supreme Court declines to hear case (The Hill)
  • CMS meets MIPS reporting goals, but thousands of doctors still face penalties (Modern Healthcare)
  • CMS, HHS and FDA to tech innovators: Here's how to win federal agencies as customers (Healthcare IT News)
Upcoming Meetings & Events Europe
  • EMA facing higher-than-expected staff losses after Brexit (PharmaTimes)
  • Samsung Phones Will Now Let You Video Chat Doctors in the UK (Fortune)
  • Pharma improves reputation among German patient groups (pharmaphorum)
  • PMCPA takes AZ to task over asthma drug press release (PMLiVE)
  • Tela Bio, Aroa Biosurgery win CE Mark for OviTex bioscaffolds (MassDevice)
  • UK’s evolution to integrated care systems will require interoperability (AllScripts)
  • Bayer Science & Education Foundation launches new round of funding: EUR 350,000 for innovative project ideas (Press)
Asia India
  • Delhi's proposal to cap drug costs worries Indian hospitals industry (Reuters)
  • Achieving universal health coverage in India (Livemint)
  • Pharma sector provides a good long-term opportunity: Sailesh Raj Bhan of Reliance Pharma Fund (Economic Times)
  • Cost effective packaging innovations taking centre stage in Indian pharma industry (Pharmabiz)
  • Jawed Zia joins as Vice President in Abbott, India (BioSpectrum)
  • ED attaches Rs 4,701 cr assets of Gujarat pharma firm (The Telegraph)
Australia
  • HBF and HCF scrap planned $4 billion health insurance merger (ABC News)
Canada
  • Health Canada wants to phase out pesticides to save the bees (Health Canada)
  • Health minister favours warnings on individual cigarettes as Ottawa outlines tobacco plan (The Canadian Press)
General Health & Other Interesting Articles
  • WATCH: Surgeons create personalized brain maps to guide safer surgeries (STAT)
  • Doctors are being more careful on opioid prescriptions (Axios)
  • A More Egalitarian Hospital Culture Is Better for Everyone (NYT)
  • A 'wake-up call' about what's killing America's young people (CNN)
  • Drug Use Rankings Show Big Surprises And Even Bigger Problems (Forbes)
  • When Scientists Develop Products From Personal Medical Data, Who Gets To Profit? (NPR)
  • Skyping the doctor? Poll shows it’s not just for the young (AP News)
  • Digital Health: "It's Not About the App" (PharmExec)
  • The key to weight loss may be right in the palm of your hand (CNBC)
  • Humans' Big Brains May Be Partly Due to Three Newly Found Genes (GEN News)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
 

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